Effect of Therapeutic Diet With Physiotherapy on Gross Motor and Cognition of Autistic Children

Not Applicable

Completed

• Conditions: Autistic Spectrum Disorder
• Interventions: Other: therapeutic diet.; Other: physiotherapy

• Registration Number: NCT06086964
• Lead Sponsor: University of Jazan

Brief Summary

: A clinical trial will be conducted to investigate the effect of free-gluten/ casein diet along with specific physiotherapy program on gross motor development and cognitive function in 3-12 years old children with ASD, And thus establish a streamlining of nutrition and physical activity for children with autism and ASD.

Detailed Description

Autism is a complex neurological and developmental disability that appears within early developmental stages of life. Autism affects the normal functioning of the brain, communication development as well as social skills of the child. Autism has been regarded as a life-long condition and it cannot be cured. However, severity may decrease through special diet and physiotherapy program.

In Saudi Arabia, the prevalence revealed that confirmed cases of ASD were 42,500, and many remained undiagnosed A target group of (60) children diagnosed with autism or ASD, attending the paediatric psychiatry outpatient clinic and autism centres will be enrolled in this clinical trial study, which will be conducted in Jazan City-Saudi Arabia.

The inclusion criteria will be as follows: (1) parental consent, (2) age 3-12 years, and (3) a diagnosis of autism or ASD. Exclusion criteria were as follows: (1) autism associated with a genetic syndrome, (2) patients with comorbidities (3) known food allergy leading to avoidance of certain foods, and (4) mother or primary caretaker not available to be adherent to the prescribed diet. Three groups will be designed: (1) autistic children with regular diet and physiotherapy program. (2) Autistic children on free gluten/casein diet and (3) Autistic children on free gluten/casein diet and subjected to specific physiotherapy program. The study will be continued for 3 months.

Study Timeline

• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Study Start: 2023-10-17
• Study First Posted: 2023-10-17
• Primary Completion: 2024-02-16
• Status Verified: 2024-03
• Study Completion: 2024-03-12
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Children diagnosed with autism spectrum disorders.
• GMFCs 4

Exclusion Criteria

• autistic children with any musculoskeletal deformities.
• autistic children with any bulbar affection lead to problem in swallowing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	therapeutic diet.	15 autistic child will receive gluten and casein free diet.
Group B	physiotherapy	15 autistic child will receive physical therapy program.
Group C	therapeutic diet.	15 autistic child will receive combination of gluten and casein free diet with physical therapy program.
Group C	physiotherapy	15 autistic child will receive combination of gluten and casein free diet with physical therapy program.

Primary Outcome Measures

Name	Time	Method
gross motor development	2 hours	Bruininks-oseretsky test of motor proficiency-1
Cognitive function	2 hours	using Bimet IQ test

Trial Locations

Locations (1)

Jazan University; 🇸🇦 Jazan, Gizan, Saudi Arabia